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FDA Probes Johnson and Johnson Recall of Children's Motrin

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New Brunswick, NJLast week, pharmaceutical manufacturer Johnson & Johnson issued a voluntary recall of about 40 over-the-counter children's medications, including Children's Motrin, Tylenol and Benadryl. While Reuters is reporting that at least 1,500 product lots have been affected, a spokesperson for the FDA told the news source that it is unclear exactly how many bottles were affected.

The FDA asked J&J to recall the products on April 30 after a routine inspection of the company's Fort Worth, Pennsylvania production facility revealed unspecified manufacturing deficiencies that may have affected quality, purity or potency.

The recall is particularly significant because it affects children. In the past, medications like Children's Motrin have been linked to debilitating conditions like Stevens Johnson Syndrome, a potentially life-threatening infection that causes severe damage to the epidermis, resulting in hypersensitivity and loss of large patches of skin.

Analysts believe that the recall could provoke the FDA to establish tighter restrictions on themanufacturing of children's pain relievers.

"These days, [the] FDA is very aggressive," a senior industry compliance consultant told Reuters. "With limited resources, they have very little patience with firms making promises. They just go right into heavier regulatory type enforcement actions to get companies to move quickly."

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